HGSI/GSK's Benlysta Gets BLySfully Clean Labeling, Escaping Feared Restrictions
This article was originally published in The Pink Sheet Daily
The indication is notable for what it does not contain, which is language specifically excluding African Americans or patients with severe active lupus nephritis or severe central nervous system lupus.
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Sales of the BLyS inhibitor disappointed at launch, but the franchise is growing double-digits and now a new, more convenient subcutaneous formula will provide another growth opportunity.
GlaxoSmithKline is working to establish an immuno-inflammation portfolio and extend learnings to other therapy areas. Sirukumab could be GSK's first new product in I&I beyond Benlysta. Chief Immunology Officer Paul-Peter Tak outlined his strategy in an interview with Scrip.
PhRMA takes an active role in shaping a new National Clinical Trial Network that aims to speed up enrollment of diverse study populations as FDA increases its push for minorities in clinical research.